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Diet and Physical Activity for Prostate Cancer
N/A
Recruiting
Led By Marian L. Neuhouser
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 40-70 years
Primary treatment is RT + ADT [Zoladex, Lupron, Degarelix, and other luteinizing hormone-releasing hormone (luteinizing hormone releasing hormone [LHRH])-directed therapies] with standard RT dose and fractionation (anti-androgen monotherapy will not be allowed
Must not have
Advanced, metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at whether a diet and exercise intervention can improve blood measures of lipids and insulin resistance in prostate cancer patients undergoing radiation therapy and androgen deprivation therapy.
Who is the study for?
Men aged 40-70 with prostate cancer set to receive radiation and hormone therapy can join. They must have a specific type of prostate cancer (adenocarcinoma), be physically able to exercise, and not already planning to start a diet or fitness program. Men with severe diabetes, recent heart attacks or strokes, cognitive issues, substance abuse problems, or advanced cancer cannot participate.
What is being tested?
The trial is testing if changing diet and increasing physical activity can prevent negative changes in metabolism caused by hormone therapy for prostate cancer. It looks at how these lifestyle changes affect blood lipids, insulin resistance, body composition, muscle health, and overall quality of life during treatment.
What are the potential side effects?
Since the intervention involves dietary changes and exercise rather than medication there are no typical 'side effects' like you'd expect from drugs; however participants may experience discomfort from new exercise routines or challenges adjusting to dietary restrictions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 70 years old.
Select...
I am receiving hormone therapy and radiation for my cancer.
Select...
My prostate cancer is confirmed and considered intermediate or high risk.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to other parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effects of the intervention on ADT-induced changes in body weight
Effects of the intervention on ADT-induced changes in fat mass
Effects of the intervention on ADT-induced changes in lean mass
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (diet, physical activity)Experimental Treatment4 Interventions
Patients attend 10 in-person or virtual sessions with a registered dietician over 6 months to receive diet instructions. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
Group II: Group II (standard lifestyle recommendations)Active Control3 Interventions
Patients receive standard lifestyle recommendations and attend an individual session with a dietitian over 20-30 minutes including US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight loss along with general behavior change suggestions for weight loss.
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Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
147,961 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
571 Previous Clinical Trials
1,340,951 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,077 Total Patients Enrolled
Marian L. NeuhouserPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 40 and 70 years old.You have poorly controlled Type 2 Diabetes (HbA1c of 10 or higher in the past year) or have had a heart attack or stroke in the last six months.I am receiving hormone therapy and radiation for my cancer.My cancer has spread to other parts of my body.My prostate cancer is confirmed and considered intermediate or high risk.You cannot be currently enrolled in a commercial or structured diet or fitness program.Your doctor has confirmed that you have problems with memory, thinking or have a history of alcohol or narcotic abuse.You are able to participate in physical exercise.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (diet, physical activity)
- Group 2: Group II (standard lifestyle recommendations)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.